510(k) Report

FDA product code · Immunology

Igg, Ferritin, Antigen, Antiserum, Control

DGDClass II21 CFR 866.5510510(k) required3 decisions since 19830 recalls

3 FDA decisions since 1983. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, immunology panel

Twenty years of DGD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · DGD

FDA has decided no DGD device since 2007.

Median 510(k) review, days · DGD

Too few DGD 510(k)s in any year since 2007 to give a median.

Recalls per year · DGD

No recall names DGD since 2007.

Adverse event reports per year · DGD

No MAUDE report names DGD since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DGD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DGD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in DGD lately?

  • K946266Ferritin Control - Level 1, 2, 3Clinical Controls, Inc. · 1995
  • K881345Imx FerritinAbbott Laboratories · 1988
  • K830229Roentgenography SetMallinckrodt Critical Care · 1983

All 3 DGD decisions →

Related product codes

Other codes under 21 CFR 866.5510.

DGP Ige, Fitc, Antigen, Antiserum, ControlPCO Immunoglobulin G Lambda Heavy And Light Chain…CZN Iga, Fitc, Antigen, Antiserum, ControlCFQ Radioimmunoassay, Immunoglobulins (G, A, M)DEW Igg, Antigen, Antiserum, ControlPDE Immunoglobulin M Kappa Heavy And Light Chain…DAH Gamma Globulin, Antigen, Antiserum, ControlPDF Immunoglobulin M Lambda Heavy And Light Chain…DFO Igg, Rhodamine, Antigen, Antiserum, ControlMLH Strip, Hama Igg, Elisa, In Vitro Test SystemCZK Iga, Rhodamine, Antigen, Antiserum, ControlDAA Igg, Peroxidase, Antigen, Antiserum, Control